Notes from Eric Kezirian, Ed Weaver, Stuart MacKay, Jolie Chang
2022 Research Day
- I. Objective Sleep Study Metrics
- a. Recommended Primary Metrics:
- i.AHI
- ii.Apnea Index
- iii.ODI (4%)
- iv.%TST90: % of sleep time spent < 90% Sat
- b. Secondary Metrics (encouraged):
- i.Supine AHI
- ii.Non-Supine AHI
- iii.Central apnea % of total events
- c.Removed:
- i.O2 Sat Nadir (LSAT)
- a. Recommended Primary Metrics:
- II. Patient Reported Outcome Measures
- a.Primary measures (committed to use):
- i.Snoring Bother: How bothersome is your snoring currently? (Likert Scale: 0=None to 10=Severe)
- ii.ESS
- iii.Global OSA-related quality of life change
- b.Secondary measures (encouraged):
- i.FOSQ
- ii.SNORE-25
- a.Primary measures (committed to use):
Permissions:
SNORE-25: Stacey Ishman, Eric Kezirian, and Ed Waver obtained permissions for use from Jay Piccirillo.
FOSQ-10: approved from Terri Weaver for research (circulated but not to be shared online); letter of agreement needed to send and receive scoring instructions.
Cardiovascular Outcome Measures
- a.Proposed measures (optional):
- i.Blood pressure (night of and morning after PSG)
- ii.De-escalation or change in blood pressure medication(s) or dosing
The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment.
Surrogate Markers |
Actual Markers |
Real Life Markers |
24-hour blood pressure | Carotid artery stenosis percentage | Incidence of acute myocardial infarction |
Systolic blood pressure | Carotid intima-media thickness | Incidence of coronary artery bypass graft
|
Diastolic blood pressure | Ejection fraction | Incidence of non-fatal cardiac events needing percutaneous coronary interventions(PCI) |
Diurnal blood pressure | Pulmonary artery pressure | Incidence of stroke |
Nocturnal blood pressure | Atrial dilatation | Incidence of atrial fibrillation/cardiac arrhythmia |
Baroreceptor sensitivity | Left ventricular hypertrophy | Deaths from AMI/stroke |
Total cholesterol (lipid profiles) | Electrophysiological studies – atrial conduction abnormalities | Hospitalisations for transient ischaemia attack |
Triglycerides | Hospitalisations for unstable angina | |
High-density lipoprotein | Incidence of congestive cardiac failure | |
Low-density lipoprotein | Incidence of pulmonary arterial hypertension | |
Markers for sympathetic activity:
|
Incidence of systemic hypertension event | |
Autonomic dysfunction measures | De-escalation or cessation of antihypertensive agents | |
Markers for oxidative stress:
|
De-escalation or cessation of statins |
ISSS 2022 Recommended Metrics for Studies on Sleep Surgery Outcomes
1. How bothersome is your snoring currently (0 = None, 10 = Severe)?
2. Epworth Sleepiness Scale (attached)
3. Global OSA-related quality of life change:
In terms of your sleep apnea and your health,has there been any change in your quality of life since the first time you came to Sleep Surgery Clinic?
If better: |
If worse: Somewhat Moderately |
Figure. Global Sleep Apnea Quality of Life Change instrument: 15-item (range —7 to +7)
4. Apnea-hypopnea index (AHI)
5.Apnea index
6. Oxygen desaturation index 4%
7. Percent of total sleep time with oxygen saturation <90%
Secondary (optional):
1. Functional Outcomes of Sleep Questionnaire – 10 (attached)
Note: Per Dr. Terri Weaver (owner of FOSQ and FOSQ-10), this questionnaire is OK to send out to ISSS members but should not be placed into the public domain, whether online or in any publication. If any members would like to use the FOSQ-10, they should complete the attached Letter of Agreement and return to Dr. Weaver at [email protected]. She will then send the scoring instructions for the FOSQ-10.
2. SNORE-25 (attached, including scoring instructions)
Note: Jay Piccirillo (owner of SNORE-25) has authorized sharing the instrument and scoring instructions with ISSS members.
3. Supine AHI
4. Non-supine AHI
5. Central apnea % of total events
Philadelphia 2022 ISSS: Drug Induced Sleep Endoscopy Research Group Meeting
ISSS Research Group participants recognize the benefit of drug induced sleep endoscopy (DISE) in the evaluation of sleep apnea. There is strong group interest in standardization of DISE, utility in patient selection, and prediction of surgical outcomes. Summaries of each presentation and discussion can be found below.
Pediatric Drug Induced Sleep Endoscopy (Dr. Erin M. Kirkham, University of Michigan)
Summary: There is no consensus or standardization in pediatrics- more research is needed
Issue Raised |
Discussion Points/Future Directions |
Anesthetic choice |
|
Scoring Pediatric DISE |
|
Indication: What is role of DISE prior to T&A? |
(Kirkham et al, 2020. doi: 10.1007/s11325-019-02006-y) |
Pharyngeal Opening Pressure (Dr. Raj C. Dedhia, University of Pennsylvania)
Summary: DISE with administration of PAP (DISE-PAP) combines endoscopic evaluation with physiologic measures of upper airway collapsibility. Pharyngeal opening pressure (PhOP) is the pressure at which inspiratory flow limitation is completely abolished and is a novel, objective measure of global airway collapsibility. There was consensus that there is a need for a measure to help predict surgical outcomes and that this should be a focus of future research on physiologic measures of airway collapse, such as PhOP
Issue Raised |
Discussion Points/Future Directions |
Standardization and Implementation |
|
Correlations |
|
Does PhOP predict surgical outcomes? |
|
Drug Induced Sleep Endoscopy and Surgical Outcomes (Dr. Olivier M. Vanderveken, Antwerp University Hospital)
Summary: DISE is viewed as a standard of care for decision making for the surgical treatment of OSA. National reimbursement and some guidelines require DISE for surgical treatment. How can we increase the evidence
Issue Raised |
Discussion Points/Future Directions |
Standardization |
Sedation
Lidocaine
Position
|
Level of collapse | There is high interest in more research regarding: Palate collapse
Epiglottic collapse
|
Cardiovascular : The ISSS Research Workshop considered a list of loosely defined “real life”, “actual” and “surrogate” cardiovascular outcome metrics in OSA treatment. A detailed sample of this list is shown in FIGURE X
24-hour blood pressure |
Actual Markers |
Real Life Markers |
Surrogate markers | Carotid artery stenosis percentage | Incidence of acute myocardial infarction |
Systolic blood pressure | carotid intima-media thickness | Incidence of coronary artery bypass graft -number of surgeries -number of vessels bypassed |
Diastolic blood pressure | Ejection fraction | Incidence of non-fatal cardiac events needing percutaneous coronary interventions(PCI) |
Diurnal blood pressure | Pulmonary artery pressure | Incidence of stroke |
nocturnal blood pressure | Atrial dilatation | Incidence of atrial fibrillation/cardiac arrythmia |
Baroreceptor sensititvity | Left ventricular hypertrophy | Deaths from AMI/stroke |
Total cholesterol (lipid profiles) | Electrophysiological studies-atrial conduction abnormalities | Hospitalisations for transient ischaemia attack |
Triglycerides | Hospitalisations for unstable angina | |
High-density lipoprotein | Incidence of congestive cardiac failure | |
Low-density lipoprotein | Incidence of pulmonary arterial hypertension | |
Markers for sympathetic activity
|
Incidence of systemic hypertension event | |
Autonomic dysfunction measures | De-escalation or cessation of antihypertensive agents | |
Markers for oxidative stress:
|
De-escalation or cessation of statins |
FIGURE X
Workshop participants considered components of the list as collectable metrics. Whilst it was recognized smaller surgical studies have shown 24 hour blood pressure improvements (Lateral pharyngoplasty reduces nocturnal blood pressure in patients with obstructive sleep apnea Laryngoscope, 124:311–316, 2014 De Paula Soares et al) or trends to change (SAMS trial), and others have demonstrated surgery reduces single measures in blood pressure (Alternations of Blood Pressure Before and After OSA Surgery Otolaryngology-Head & Neck surgery, Vol 163, Issue 4, 2020,Redefining the Timing of Surgery for Obstructive Sleep Apnea in Anatomically Favorable Patients Laryngoscope, 124:S1–S9, 2014 Rotenberg et al,Blood pressure after Modified Uvulopalatopharyngoplasty: results from the SKUP3 randomized controlled trial. Sleep Medicine Vol 34 June 2017, p156-161, Fehrm et al), the workshop committee felt it best that such studies were performed as single or multi-center trials, rather than ISSS database collection analyses.
In terms of “real life” metrics of cardiovascular outcomes following OSA surgery, the workshop recognized excellent large database study publications (for example Ibrahim et al JAMAOtolaryngolHeadNeckSurg.doi:10.1001/jamaoto.2020.5179) and single center long term observational studies (Peker Y et al doi:10.1164/rccm.2105124). It was deemed appropriate that such studies are confined to larger database sets and interested institutions, rather than ISSS member collectives.
“Actual” metrics, such as the degree of carotid intimal thickening, could also be utilized in units with the investment, interest and ability to study such markers. Future pathways may also involve select sites evaluating hypoxic burden (Azarbarzin et al European Heart Journal 2019 40 1149-1157).
Despite the above, interested members were encouraged to collect “night of and morning after” in laboratory polysomnography blood pressure readings, but recent direction towards level II studies may restrict the
Issue Raised |
Specific Parameters |
Challenges |
Committee Consensus |
Body Mass Index | 32 | Uncertain effect of HGNS implantation in this group | More Research recommended re: Implantation in this range |
Apnea Hypopnea | 65 | Uncertain effect of HGNS implantation in this group | More Research recommended re: Implantation in this range |
Titration Polysomnography following HGNS Implatation | Titration AHI (+other) Vs Whole-night Average AHI (+other) | Uncertain benefit in reporting AHI and other outcomes based on Titration Polysomnography; Titration algorithms are currently lacking | Utilize Titration Polysomnography in select circumstances only; report Whole- night average AHI in research (within 12 months); practical clinician consideration recommended |
Current Registries inadequate | Timing of Outcome Measures | Timing of collection of Outcome Measures is non-uniform/broad | Genuine Registry with time specific data collection required |
Pre-Implantation Clinician Counselling | Assessment, Discussion and Decision Making | Some clinicians and centers are inadequately describing other primary, alternative and salvage OSA treatment options | Consider patient co- morbidities, anatomy, physiology and clinician expertise prior to implantation. Discussion requires realistic goals and expectations |
Adherence to Therapy post- implantation | Compliance + Compliance in the setting of subjective and objective improvement | Documentation of symptomatic/subjectiv e improvement, bed partner input; Residual disease may not be relevant in the setting of symptomatic improvement and reduction in disease burden | Clinicians need to consider compliance with therapy, symptomatic improvement, and reduction in disease burden in determining outcomes |